Echo and Electrocardiographic Findings in Children With Bronchial Asthma At Sohag University Hospital

October 10, 2024 updated by: Safa Atef Abodaif, Sohag University
Bronchial asthma is a common respiratory disorder among children, worldwide. Asthma is characterized by chronic inflammation and remodeling of the airways induced by recurrent exposure to hypoxemia that leads to repeated tissue injury and repair. The interaction between respiratory diseases and cardiovascular function is complex . Cardiac dysfunction can be attributed to pulmonary hypertension (PH) secondary to recurrent hypoxia in patients with bronchial asthma. PH affects the pulmonary vasculature by releasing various cytokines leading to pulmonary vasoconstriction and enhancing the remodeling process with muscularization and proliferation of the vascular media and intima . Other hypotheses concluded that the exaggerated respiratory efforts may raise the intrathoracic pressure and increase right ventricle (RV) afterload and consequently RV hypertrophy and/or dilatation . Children with severe bronchial asthma can experience cor pulmonale later in life, but little is known about the early cardiac changes that might be present during childhood especially for mild or moderate persistent asthma. Some studies have reported right ventricular dysfunction as the earliest hemodynamic change among those cases . Other studies did not report these results and reported impaired systolic function of the left ventricle (LV) even before diastolic dysfunction . Insufficient control of BA, in turn, can cause the formation of various pathological conditions. For example, there are studies showing the risk of cardiac arrhythmias and conduction disorders in patients with uncontrolled BA due to functional changes or pathological remodeling of the myocardium . Atrial remodeling, which is the pathomorphological basis of serious supraventricular cardiac arrhythmias, has a more rapid progression with poor BA control and is formed as a result of excessive stretching of the atrial wall, as well as other adverse factors . The connection between BA and supraventricular arrhythmias, including atrial fibrillation (AF), was noted in studies by Cepelis et al. Available data indicate that in the adult population, cardiac arrhythmias are significantly more common in patients with BA than in those without it (9). The results of a Norwegian population study HUNT study, demonstrate that the risks of supraventricular arrhythmias and AF are increased in patients with an uncontrolled BA . Electrocardiography (ECG) is the universal screening method for assessing the state of the atrial myocardium and the conducting system of the heart. According to German et al. ECG analysis can make a significant input to the assessment of the risk of formation of supraventricular rhythm and conduction disorders. Therefore, the analysis of the atrial component of the ECG, and atrioventricular conduction in patients with BA is an important component of the management of these patients, especially in pediatric practice. Consequently, the study of the characteristics of the ECG and its supraventricular component in children with BA is relevan

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Eman M Fahmy, assistant professor

Study Locations

  • Egypt
      • Sohag, Egypt, Sohag
        • Sohag University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Age range: 5-18 years 2. Confirmed diagnosis of bronchial asthma, made in accordance with current international and national consensus documents

Exclusion Criteria:

  • . Known congenital heart disease 2. Presence of acute infectious diseases and fever 3. Diabetes 4. Autoimmune disorders 5. Primary immunodeficiency 6. Cancer 7. Current use of oral glucocorticoids 8. Other chronic respiratory conditions 9. Systemic diseases affecting the cardiovascular system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acute Exacerbation Group
an acute attack, at least 1 month after attack. a. Mild acute exacerbation b. Moderate acute exacerbation c. Severe acute exacerbation, according GINA 2024.
Procedure: Echocardiography

Transthoracic echocardiography

• Parameters assessed:

  • Right ventricular dimensions and function
  • Pulmonary artery pressure estimation
  • Valvular function assessment
  • Left ventricular dimensions (end-diastolic and end-systolic)o Left ventricular function (ejection fraction, fractional shortening)
Procedure: Electrocardiography

Standard 12-lead ECG recording

• Parameters assessed:

  • Heart rate and rhythm
  • P-wave morphology
  • PR interval
  • QRS complex duration and morphology
  • ST-segment changes
  • T-wave abnormalities
  • QT interval
Active Comparator: Stable Asthma Group
Patients attending routine follow-up visits with well-controlled asthma
Procedure: Echocardiography

Transthoracic echocardiography

• Parameters assessed:

  • Right ventricular dimensions and function
  • Pulmonary artery pressure estimation
  • Valvular function assessment
  • Left ventricular dimensions (end-diastolic and end-systolic)o Left ventricular function (ejection fraction, fractional shortening)
Procedure: Electrocardiography

Standard 12-lead ECG recording

• Parameters assessed:

  • Heart rate and rhythm
  • P-wave morphology
  • PR interval
  • QRS complex duration and morphology
  • ST-segment changes
  • T-wave abnormalities
  • QT interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in ECG parameters from baseline to follow-up
Time Frame: 1 year

Standard 12-lead ECG recording

• Parameters assessed:

  • Heart rate and rhythm
  • P-wave morphology
  • PR interval
  • QRS complex duration and morphology
  • ST-segment changes
  • T-wave abnormalities
  • QT interval
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in echocardiographic parameters from baseline to follow-up
Time Frame: 1year

Transthoracic echocardiography

• Parameters assessed:

  • Right ventricular dimensions and function
  • Pulmonary artery pressure estimation
  • Valvular function assessment
  • Left ventricular dimensions (end-diastolic and end-systolic)
  • Left ventricular function (ejection fraction, fractional shortening)
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 10, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-24 - 09- 04MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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